Effectiveness and Safety of Bu Shen Kai Qiao Fang in the Treatment of Alzheimer’s Disease: Study Protocol for a Multicenter, Prospective, Real-World Clinical Trial

Figures & data

Figure 1 Flow chart of the study method. BSKQF: Bu Shen Kai Qiao Fang.

Box 1 Alzheimer’s Disease Clinical Diagnostic Criteria

Dementia can be diagnosed when the following cognitive or behavioral (neuropsychiatric) symptoms occur: Obvious effects on normal work and daily social activities or interpersonal relations; and Represent a decline from previous levels of functioning and performing; and The above changes cannot be explained by delirium or major psychiatric disorder; Cognitive impairment is detected and diagnosed by combining the following two forms of information Medical history provided by the patient and the knowledgeable informant An objective cognitive assessment, either a “bedside” mental status examination or neuropsychological testing. Neuropsychological testing should be performed when the routine history and bedside mental status examination cannot provide a confident diagnosis. Showing cognitive or behavioral impairment in at least two of the following domains: The ability to acquire and remember new information, with symptoms including: repeating questions or conversations, misplacing personal items, forgetting events or appointments, and getting lost on familiar routes. Reasoning and ability to handle complex tasks, and reduced judgment, with symptoms including: inability to anticipate security risks, manage finances, make decisions, or plan for complex or continuous activities. Spatial vision, with symptoms including: inability to recognize faces or common objects, or to find objects in the immediate vicinity, even with good vision, to operate simple tools, or to point clothes at the body. Language function (speaking, reading, writing), with symptoms including: difficulty thinking of common words when speaking, hesitation; conversation, spelling and handwriting mistakes. Changes in personality, behavior or daily demeanor, with symptoms including: unusual mood swings such as anxiety, lack of energy, impaired initiative, apathy, loss of positivity, decreased desire to socialize, decreased interest in previous activities, loss of empathy, compulsive or compulsive behavior, socially unacceptable behavior.

Table 1 Schedule of Intervention and Assessments

Items	Study Phase
	Screening/Enrolment Baseline	Follow-Up (Months)
		1	2	3
General
Signed Informed Consent	√
Inclusion and exclusion criteria	√
General information	√
General physical examination	√
History of Alzheimer Disease	√
Medical history and allergies	√
History of other mental illness	√
Urine HCG (female patients)	√
Concomitant disease and treatment	√
Combined medication	√	√	√	√
Effectiveness indicators
MMSE scale	√	√	√	√
MoCA scale	√	√	√	√
Detection of plasma Tau protein	√			√
Detection of plasma Aβ42 protein	√			√
Evaluation Criteria for TCM Syndrome Effect	√	√	√	√
MRI examination	√			√
Safety observation
Electrocardiogram	√			√
Blood routine	√			√
Urine routine	√			√
Fecal routine and occult blood test	√			√
Electrolyte, liver and kidney function test	√			√
Adverse events	√			√
Appointment for next follow-up	√	√	√
Research conclusion				√